immunogenicity and safety of kinrix + (measles mumps rubella) mmr vaccine with and without varicella vaccine in healthy children 4-6 years

Conditions: Tetanus; Acellular Pertussis; Diphtheria

Summary: the purpose of the study is to evaluate the immunogenicity and safety of kinrix when co-administered with varicella (varivax® \[varicella virus vaccine live\], merck and company) and (measles mumps rubella) mmr vaccines, compared to kinrix co-administered with mmr vaccine alone. both kinrix and the second dose of varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. the aim of this trial is to demonstrate that co-administered varivax does not negatively affect the immunogenicity or reactogenicity of kinrix.

subjects 4-6 years of age will be randomized into two groups to receive either kinrix, varivax and m-m-rii on day 0 (group 1) or kinrix and m-m-rii on day 0 and varivax at month 1(group 2). all subjects in both groups to provide blood samples prior to vaccination on day 0 and at month 1 (for group 2, blood sampling is prior to vaccination with varivax). duration of the study will be approximately 6 months for each subject with a safety telephone contact 6 months after vaccinations.

Eligibility criteria:
inclusion criteria: * subjects for whom the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol. * a male or female child between 4 and 6 years of age, inclusive. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * having received 4 doses of (diphtheria, tetanus acellular pertussis) dtap vaccine using pediarix and/or infanrix, and 3 doses of poliovirus vaccine using pediarix and/or (inactivated poliovirus vaccine, aventis pasteur) ipol in the first 2 years of life. * previously received 1 dose of m-m-rii and varivax (separate or combined) in the second year of life. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product or device. * history of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, rubella or varicella disease, or of vaccination against these diseases given after the second year of life. * known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination. * poliovirus vaccination with one or more doses of (oral polio virus) opv vaccine. * administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at day 30. * chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at day 30. * administration of immunoglobulins and/or any blood products at any time prior to study vaccination or planned administration during the study period ending at day 30. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy. * major congenital defects or serious chronic illness. * acute disease at the time of enrolment. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * history of anaphylactic reaction to egg proteins or previous doses of the vaccine(s). * encephalopathy within 7 days of administration of previous dose of infanrix or pediarix. * fever \>=40.5°c or 104.9°f (rectal temperature) (39.5°c or 103.1°f, oral/axillary) within 48 hours of previous dose of infanrix or pediarix not due to another identifiable cause. * collapse or shock-like state within 48 hours of previous dose of dtap or dtap-containing vaccine. * persistent, severe, inconsolable screaming or crying lasting ³3 hours occurring within 48 hours of administration of previous dose of dtap or dtap-containing vaccine. * thrombocytopenia following a previous dose of m-m-rii or its component vaccines * inability to contact a parent/guardian of the subject by telephone. * blood dyscrasias, leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems. * family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject has been demonstrated. * residence in the same household as the following persons: * new-born infants (0-4 weeks of age). * pregnant mother/women without documented positive history of chickenpox disease or laboratory evidence of prior varicella vaccination. * pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history. * persons with known immunodeficiency. * active untreated tuberculosis.

Keywords: co-administration immunization preschool booster